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Human Drugs

FDA Wants Testosterone Therapy Labels Updated

HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical evidence.

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Human Drugs

Review Memo Dismisses Hoegs Block on Tzield Approval

FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for T...

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Human Drugs

Grace Therapeutics Preparing NDA Resubmission

Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.

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Medical Devices

FDA Updates Device READI-Home Innovation Challenge Initiative

FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical device...

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Leadership Changes Affect FDA Priorities: Mintz Post

Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignation.

Animal Drugs

Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

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Human Drugs

Evaluate Generic Bicalutamide Manufacturers: Petition

A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in gener...

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Human Drugs

Agency Seeks Updated Generic Accutane Labels

FDA asks manufacturers of generic Accutane to update the drugs labeling.

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Biologics

FDA Backs Accelerated Pathway for UniQure Huntington's Therapy

FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for t...

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Human Drugs

FDA, African Medicines Agency Agreement on Regulatory Harmonization

FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the U.S. regulator and ...